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Annex D of 62366 refers to using "production units" for final validation. Since Annex D is an informative guidance section of the standard, I am thinking that it is not a requirement to use production units and would like to hear from any of you that have the relevant regulatory knowledge or practical experience.
Of course the risk is that if non-production units are used for final usability validation and any changes are made to the device after validation but prior to production that may affect the usability of the device or risk assessment, then the final usability validation should redone. However, in my thinking, there is a potentially greater cost result if final production units are used for the validation and the units do not pass the validation. Then one may likely need to enter back into R&D (Design) to resolve the problem by design/engineering, and subsequently re-validate.
Therefore I am thinking that it will be best for our company to use DVT (design verification testing) units for final usability validation. Our DVT units will have components equivalent to final production units including injection molded housings. The things that may change will be the manufacturing instructions because they will likely be scaled to be more effective for larger production quantities, but I don't see that having any effect on device usability.
Thanks for any experience and knowledge!
Ref.:
D.4.7.3 Production unit final VALIDATION
Evaluation of production units employ methods to assure that the MEDICAL DEVICE meets
USER needs and INTENDED USE (i.e. design VALIDATION).
Of course the risk is that if non-production units are used for final usability validation and any changes are made to the device after validation but prior to production that may affect the usability of the device or risk assessment, then the final usability validation should redone. However, in my thinking, there is a potentially greater cost result if final production units are used for the validation and the units do not pass the validation. Then one may likely need to enter back into R&D (Design) to resolve the problem by design/engineering, and subsequently re-validate.
Therefore I am thinking that it will be best for our company to use DVT (design verification testing) units for final usability validation. Our DVT units will have components equivalent to final production units including injection molded housings. The things that may change will be the manufacturing instructions because they will likely be scaled to be more effective for larger production quantities, but I don't see that having any effect on device usability.
Thanks for any experience and knowledge!
Ref.:
D.4.7.3 Production unit final VALIDATION
Evaluation of production units employ methods to assure that the MEDICAL DEVICE meets
USER needs and INTENDED USE (i.e. design VALIDATION).